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Group Intervention on Executive Function in Children With Autism Spectrum Disorder

Primary Purpose

Autism Spectrum Disorder, Autism

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
ApisMela protocol
"Unstuck and on Target" protocol
Sponsored by
Istituto per la Ricerca e l'Innovazione Biomedica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Autism Spectrum Disorder focused on measuring autism, children, executive functions

Eligibility Criteria

7 Years - 13 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Children with diagnosis of autism and autism spectrum disorder Exclusion Criteria: Presence of other medical disorders

Sites / Locations

  • Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

"ApisMela/Unstuck" Group

"Unstuck/ApisMela" Group

Arm Description

Six children belonging to the experimental group. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Being a crossover clinical trial, the group ending with the ApisMela protocol continues with the Ustuck protocol.

Six children belonging to the experimental group. Unstuck protocol teaches people to be more flexible, skillful in planning and goal-oriented. Being a crossover clinical trial, the group ending with the Unstuck protocol continues with the ApisMela protocol.

Outcomes

Primary Outcome Measures

Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months. The WISC-IV scales are as follows: index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max 160). For each sub-scale higher score corresponds to better performance.
Changes in NEuroPSYcology second edition (NEPSY-II) evaluations
NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age. Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min <2% - max >75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance.

Secondary Outcome Measures

Full Information

First Posted
July 14, 2023
Last Updated
July 27, 2023
Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Collaborators
Fondazione di Comunità di Messina onlus
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1. Study Identification

Unique Protocol Identification Number
NCT05977075
Brief Title
Group Intervention on Executive Function in Children With Autism Spectrum Disorder
Official Title
Training "Unstuck and On Target! Second Edition" Versus Training "ApisMela"
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 1, 2022 (Actual)
Primary Completion Date
June 30, 2023 (Actual)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Istituto per la Ricerca e l'Innovazione Biomedica
Collaborators
Fondazione di Comunità di Messina onlus

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Autism is a developmental disorder characterized by difficulties in social communication, repetitive behaviors, and social interaction. A key aspect of autism concerns executive functions, which are a set of cognitive processes that regulate attention, planning, inhibition, and impulse control. These functions are often impaired in children with autism, affecting their learning and daily functioning. The present protocol aims to test the first absolute and then comparative effectiveness of two executive function development programs: the "APISMELA" training and the "UNSTUCK & ON TARGET! SECOND EDITION". Two groups will be held at the same time and will conduct the two programs in reverse order. In fact, the protocol is divided into two phases. Participants subjected to the APISMELA group, finished the intervention sessions will conduct an interim evaluation and then begin the intervention phases of the UNSTUCK & ON TARGET! SECOND EDITION protocol. Participants subjected to the UNSTUCK & ON TARGET! SECOND EDITION group, finished the intervention sessions will conduct an interim evaluation and then begin the intervention phases of the APISMELA protocol. Group intervention programs were chosen for two reasons: group intervention compared with individual intervention have lower costs for patients and their families and thus higher overall social acceptability. The second is that group intervention within the social-constructivist paradigm, to which the two chosen programs belong, becomes a fundamental resource for stimulating that augmentative learning that is a source of development on the cognitive and conceptual levels for human beings.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Autism Spectrum Disorder, Autism
Keywords
autism, children, executive functions

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
"ApisMela/Unstuck" Group
Arm Type
Experimental
Arm Description
Six children belonging to the experimental group. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Being a crossover clinical trial, the group ending with the ApisMela protocol continues with the Ustuck protocol.
Arm Title
"Unstuck/ApisMela" Group
Arm Type
Experimental
Arm Description
Six children belonging to the experimental group. Unstuck protocol teaches people to be more flexible, skillful in planning and goal-oriented. Being a crossover clinical trial, the group ending with the Unstuck protocol continues with the ApisMela protocol.
Intervention Type
Other
Intervention Name(s)
ApisMela protocol
Intervention Description
The activities and games proposed by this protocol are offered in a sequence characterized by increasing complexity. The same function is stimulated with varied tasks because the repetitiveness of the same task negatively affects skill generalization. ApisMela training teaches to focus on the purpose of the task, check that you understand it, and make explicit the procedures to be implemented. Language plays a crucial role, participants are encouraged to use speech as a tool for attention regulation and cognitive processing. It's divided into 20 sessions: a weekly group meeting of one hour and thirty.
Intervention Type
Other
Intervention Name(s)
"Unstuck and on Target" protocol
Intervention Description
The protocol teaches people to be more flexible, skillful in planning and goal-oriented. It is useful for moving more easily from one topic to another and from one task to another, considering new ideas or another person's point of view, generalizing skills learned across contexts so that teachers, parents and therapists can focus more on educational aspects and less on behavioral management. It is divided into 20 sessions: a weekly group meeting of one hour and thirty minutes. A homework sheet is provided for each session to consolidate the skill learned and generalize it outside the work setting. Parents have an active role in performing the task.
Primary Outcome Measure Information:
Title
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV)
Description
Wechsler Intelligence Scale for Children Fourth edition (WISC-IV) is a clinical tool for assessing the cognitive abilities of children and young people between the ages of 6 years and 16 years and 11 months. The WISC-IV scales are as follows: index of verbal comprehension (ICV), range weighted scores (min 46 - max154); index visuoperceptual reasoning (IRP), range weighted scores (min 41- max 159); index working memory (IML) range weighted scores (min 46 - max 154); processing speed index (IVE) range weighted scores (min 47 - max 153); intelligence quotient IQ (min 40 - max 160). For each sub-scale higher score corresponds to better performance.
Time Frame
The evaluation session will be scheduled pre-intervention (T0). The test needs approximately 65-80 minutes to complete.
Title
Changes in NEuroPSYcology second edition (NEPSY-II) evaluations
Description
NEuroPSYcology second edition (NEPSY-II) is the most internationally known battery for assessing neuropsychological development in developmental age. Each NEPSY-II test provides raw scores that must be converted into scalar scores (min 1 - max 19) or percentile scores (min <2% - max >75%) according to the conversion tables in the manual. For each sub-scale higher scores correspond to better performance.
Time Frame
The tests will be scheduled pre intervention (T0), at 6 months (T1) and at the study conclusion,about 1 year (T2).The T1 and T2 evaluations were conducted to determine whether the protocols carried out made a change.The test needs about 120-180 minutes.

10. Eligibility

Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
13 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Children with diagnosis of autism and autism spectrum disorder Exclusion Criteria: Presence of other medical disorders
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Flavia Marino
Phone
+393395798263
Email
flavia.marino@irib.cnr.it
First Name & Middle Initial & Last Name or Official Title & Degree
Giovanni Pioggia
Phone
+393203390892
Email
giovanni.pioggia@irib.cnr.it
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Flavia Marino
Organizational Affiliation
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institute for Biomedical Research and Innovation (IRIB) - National Research Council (CNR)
City
Messina
ZIP/Postal Code
98164
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Flavia Marino
Email
flavia.marino@irib.cnr.it
First Name & Middle Initial & Last Name & Degree
Giovanni Pioggia
Email
giovanni.pioggia@irib.cnr.it
First Name & Middle Initial & Last Name & Degree
Flavia Marino
First Name & Middle Initial & Last Name & Degree
Giovanni Pioggia
First Name & Middle Initial & Last Name & Degree
Paola Chilà
First Name & Middle Initial & Last Name & Degree
Roberta Minutoli
First Name & Middle Initial & Last Name & Degree
Noemi Vetrano
First Name & Middle Initial & Last Name & Degree
Chiara Failla
First Name & Middle Initial & Last Name & Degree
Germana Doria
First Name & Middle Initial & Last Name & Degree
Ileana Scarcella
First Name & Middle Initial & Last Name & Degree
Serena Previti
First Name & Middle Initial & Last Name & Degree
Chiara Rando
First Name & Middle Initial & Last Name & Degree
David Vagni
First Name & Middle Initial & Last Name & Degree
Marco Cadavero
First Name & Middle Initial & Last Name & Degree
Roberta Torrisi

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
Citation
Nydén, A., Gillberg, C., Hjelmquist, E., & Heiman, M. (1999). Executive function/attention deficits in boys with Asperger syndrome, attention disorder and reading/writing disorder. Autism, 3(3), 213-228.
Results Reference
background
PubMed Identifier
22509161
Citation
Jolles DD, Crone EA. Training the developing brain: a neurocognitive perspective. Front Hum Neurosci. 2012 Apr 9;6:76. doi: 10.3389/fnhum.2012.00076. eCollection 2012.
Results Reference
background
Citation
American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders, 5th ed.; American Psychiatric Publishing: Washington, DC, USA, 2013.
Results Reference
background
PubMed Identifier
24994650
Citation
Wilson TD, Reinhard DA, Westgate EC, Gilbert DT, Ellerbeck N, Hahn C, Brown CL, Shaked A. Social psychology. Just think: the challenges of the disengaged mind. Science. 2014 Jul 4;345(6192):75-7. doi: 10.1126/science.1250830.
Results Reference
background
PubMed Identifier
24256459
Citation
Kenworthy L, Anthony LG, Naiman DQ, Cannon L, Wills MC, Luong-Tran C, Werner MA, Alexander KC, Strang J, Bal E, Sokoloff JL, Wallace GL. Randomized controlled effectiveness trial of executive function intervention for children on the autism spectrum. J Child Psychol Psychiatry. 2014 Apr;55(4):374-83. doi: 10.1111/jcpp.12161. Epub 2013 Nov 21.
Results Reference
background
Citation
Orsolini, Margherita & Melogno, Sergio & Santese, Angela & Toma, Chiara & Latini, Nausica & Salomone, Samantha & Andreagiovanni, Jacopo. (2019). "Pensando si Impara" STIMOLARE L'ATTENZIONE, LE FUNZIONI ESECUTIVE E LA MEMORIA DI LAVORO NEI BAMBINI CON BISOGNI EDUCATIVI SPECIALI.
Results Reference
background
PubMed Identifier
32699642
Citation
Dickson KS, Aarons GA, Anthony LG, Kenworthy L, Crandal BR, Williams K, Brookman-Frazee L. Adaption and pilot implementation of an autism executive functioning intervention in children's mental health services: a mixed-methods study protocol. Pilot Feasibility Stud. 2020 Apr 27;6:55. doi: 10.1186/s40814-020-00593-2. eCollection 2020.
Results Reference
background
PubMed Identifier
33570249
Citation
Cannon J, O'Brien AM, Bungert L, Sinha P. Prediction in Autism Spectrum Disorder: A Systematic Review of Empirical Evidence. Autism Res. 2021 Apr;14(4):604-630. doi: 10.1002/aur.2482. Epub 2021 Feb 11.
Results Reference
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Group Intervention on Executive Function in Children With Autism Spectrum Disorder

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